Lenvima

(Lenvatinib)

ApprovedSmall molecule

Lenvatinib is used to treat certain types of cancer including thyroid cancer, kidney cancer, and liver cancer by blocking proteins that help cancer cells grow and spread.[2] Lenvima is currently approved and in use across 90 indications[4].[1]

Lenvima is one of 1305 small molecule programs targeting Gastroesophageal Junction Adenocarcinoma. It is currently in Approved.

Indications

420

Total Trials

102

Active Trials

1,304

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Gastroesophageal Junction AdenocarcinomaApproved

MetastasisActive, not recruiting

Esophageal Squamous Cell CarcinomaNot yet recruiting

Esophageal CarcinomaActive, not recruiting

Clear Cell Renal CarcinomaApproved

ParagangliomaActive, not recruiting

Hepatitis B Virus InfectionActive, not recruiting

Thyroid NeoplasmActive, not recruiting

Liver TransplantActive, not recruiting

Kidney CancerActive, not recruiting

Gastroesophageal Junction AdenocarcinomaApproved

Approved

MetastasisPhase 2

Active, not recruiting

Esophageal Squamous Cell CarcinomaPhase 2

Not yet recruiting

Esophageal CarcinomaPhase 3

Active, not recruiting

Clear Cell Renal CarcinomaApproved

Approved

ParagangliomaPhase 2

Active, not recruiting

Hepatitis B Virus InfectionPhase 2/Phase 3

Active, not recruiting

Thyroid NeoplasmPreclinical

Active, not recruiting

Liver TransplantPreclinical

Active, not recruiting

Kidney CancerPhase 3

Active, not recruiting

Showing 10 of 90 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Lenvima

Eisai

Approved

3 2

Adriamycin

GGynecologic Oncology Group

Preclinical

87 3

Blenoxane

Bristol-Myers Squibb

Preclinical

1 4

Avastin

Roche

Preclinical

4 5

Chirocaine

PPurdue Pharma LP

Preclinical

1 6

Aquasol E

NNational Eye Institute (NEI)

Preclinical

—7

Vfend

PPrism Pharmaceuticals

Motexafin Gadolinium

1 9

Conventional Chemotherapy

SShanghai Jiao Tong University School of Medicine

Preclinical

1 10

Iniparib

Sanofi

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

N/ARecruiting

Safety and Efficacy

NCT06519721

Phase 2Recruiting

First-Line Treatment

NCT06157996

Phase 2Recruiting

Unresectable

NCT05992584

N/ARecruiting

Hepatocellular Carcinoma

NCT06740370

Not yet recruiting

Advanced

NCT07466225

Phase 2Recruiting

Gastric Cancer

NCT06383559

Clinical

Trials by Indication[1]

Hepatocellular Carcinoma45 trials

Hepatic Arterial Infusion Combined With Lenvatinib and Camrelizumab for Unresectable Hepatocellular Carcinoma

Completed·NNanfang Hospital, Southern Medical University·Phase 2·NCT05003700·39 enrolled

Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant

Recruiting·EEmory University·Phase 2·NCT05103904·19 enrolled

A Single-Arm, Multicenter, Exploratory Clinical Study of TACE Combined With Iparomlimab and Tuvonralimab Injection (QL1706) and Lenvatinib for Perioperative Treatment of Resectable Hepatocellular Carcinoma

Not yet recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT07131501·48 enrolled

Show 42 more trials

TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma (Prolong)

Unknown status·ZZhejiang Cancer Hospital··NCT04560751·300 enrolled

Lenvatinib Following Liver Transplantation in Patients of Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Unknown status·RRenJi Hospital·Phase 2/3·NCT04319484·108 enrolled

Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma

Recruiting·GGuangdong Provincial People's Hospital·Phase 2·NCT05954897·29 enrolled

A Multicenter Registry Study on Stage III Hepatocellular Carcinoma in Unresectable CNLC Liver Cancer

Not yet recruiting·FFudan University··NCT05660213·750 enrolled

Combined HAIC, Lenvatinib and Cadonilimab As Conversion Therapy for Unresectable Hepatocellular Carcinoma

Recruiting·TTongji Hospital·Phase 2·NCT06187961·36 enrolled

Icaritin Soft Capsules+TACE+Immunotherapy+Targeted Therapy Versus TACE+Immunotherapy+Targeted Therapy for Unresectable Hepatocellular Carcinoma

Not yet recruiting·ZZhiyong Huang·Phase 1/2·NCT06896396·60 enrolled

The Safety and Efficacy of Transarterial Chemoembolization (TACE) + Lenvatinib + Programmed Cell Death Protein 1 (PD-1) Antibody of Advanced Unresectable Hepatocellular Carcinoma

Completed·XXinrui Zhu，MD·Phase 1/2·NCT04997850·142 enrolled

Lenvatinib Combined With Gefitinib in the Treatment of Lenvatinib-resistant Hepatocellular Carcinoma

Completed·RRenJi Hospital·N/A·NCT04642547·30 enrolled

TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT07487662·90 enrolled

Lenvatinib After Progression on Atezolizumab-bevacizumab in Hepatocellular Carcinoma

Active, not recruiting·—·Phase 2·NCT06138769·50 enrolled

Palliative Hepatectomy Combined With Targeted Therapy and Immunotherapy for Advanced Hepatocellular Carcinoma

Recruiting·ZZhiyong Huang·Phase 1·NCT06470256·50 enrolled

Cryoablation Combined with Tislelizumab Plus Lenvatinib As Second-line or Later Therapy in Advanced Hepatocellular Carcinoma

Recruiting·FFudan University·Phase 2·NCT05057845·25 enrolled

Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma

Completed· BeiGene logo

BeiGene·Phase 2·NCT04401800·64 enrolled

Combined HAIC, TKI/Anti-VEGF and ICIs as Conversion Therapy for Unresectable Hepatocellular Carcinoma

Recruiting·ZZe-yang Ding, MD··NCT05713994·300 enrolled

A Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection

Not yet recruiting·TTongji Hospital·Phase 3·NCT06089382·104 enrolled

A Study of Tegavivint (BC2059) in Patients With Advanced Hepatocellular Carcinoma

Recruiting·IIterion Therapeutics·Phase 1/2·NCT05797805·178 enrolled

A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma

Completed· Eisai logo

Eisai··NCT04763408·335 enrolled

Pharmacokinetic Study of E7080/Lenvatinib in Chinese Patients With Unresectable Hepatocellular Carcinoma (HCC)

Completed· Eisai logo

Eisai·Phase 1·NCT02953743·25 enrolled

Lenvatinib Treatment in Waiting List of Liver Transplantation After TACE Failure in Patients With Hepatocellular Carcinoma

Active, not recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 1/2·NCT05901194·25 enrolled

Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT04246177·480 enrolled

Efficacy and Safety of Intratumoral Injection of Recombinant Human Adenovirus Type 5 Combined With Tislelizumab and Lenvatinib in the Treatment of Advanced Hepatocellular Carcinoma

Not yet recruiting·TThe First Affiliated Hospital of Bengbu Medical University·Phase 2·NCT06253598·30 enrolled

A Study of BL-B01D1 Combined With Lenvatinib in Patients With Advanced Hepatocellular Carcinoma

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06986785·46 enrolled

Combination of SBRT, PD-L1 Inhibitor, and Lenvatinib in Hepatocellular Carcinoma (HSBRT2401)

Recruiting·MMian XI·Phase 2·NCT06261125·60 enrolled

Perioperative Pembrolizumab and Lenvatinib in Resectable Hepatocellular Carcinoma (HCC)

Recruiting·UUniversity College, London·Phase 2·NCT05185739·60 enrolled

Neoadjuvant Therapy of iIparomlimab and Tuvonralimab Combined With Lenvatinib for Hepatocellular Carcinoma

Not yet recruiting·PPeking Union Medical College Hospital·Phase 2·NCT07014150·30 enrolled

Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma

Recruiting·SSun Yat-sen University·N/A·NCT05444478·274 enrolled

Combined TACE, TKI/Anti-VEGF and ICIs as Conversion Therapy for Advanced Hepatocellular Carcinoma

Recruiting·TTongji Hospital··NCT05717738·300 enrolled

A Study of Overall Survival in Participants With Unresectable Hepatocellular Carcinoma

Completed· Eisai logo

Eisai··NCT04008082·412 enrolled

Fostrox Plus Lenvatinib vs Lenvatinib in Advanced Hepatocellular Carcinoma After First-line Immunotherapy

Not yet recruiting·—·Phase 2·NCT07493668·80 enrolled

A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma

Recruiting·AAkeso·Phase 3·NCT06371157·469 enrolled

Trial to Evaluate Safety and Efficacy of Treatment of Physician Choice (TPC) Following First-Line Treatment of Lenvatinib in Subjects With Unresectable Hepatocellular Carcinoma (uHCC)

Terminated· Eisai logo

Eisai·Phase 2·NCT03433703·8 enrolled

TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma

Unknown status·SShanghai Zhongshan Hospital·Phase 2·NCT04490694·54 enrolled

Lenvatinib Combined With TACE to Prevent the Recurrence in High-risk Patients With Hepatocellular Carcinoma

Unknown status·FFudan University·N/A·NCT03838796·297 enrolled

Radiofrequency Ablation Combined With Toripalimab and Lenvatinib in the Treatment of Short-term Recurrent Hepatocellular Carcinoma.

Unknown status·HHenan Cancer Hospital·N/A·NCT05162898·90 enrolled

Lenvatinib Combined Anti-PD1 Antibody for the Advanced Hepatocellular Carcinoma

Completed·SSun Yat-sen University··NCT04627012·600 enrolled

TACE Combined With Lenvatinib and PD-1 Inhibitor for Ruptured Hepatocellular Carcinoma

Recruiting·SSun Yat-sen University·N/A·NCT06740370·32 enrolled

Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Budigalimab in Adult Participants With Hepatocellular Carcinoma (HCC)

Active, not recruiting· AbbVie logo

AbbVie·Phase 2·NCT05822752·130 enrolled

Microvascular Invasion for Guiding Treatment of Barcelona Clinic Liver Cancer Stage B Hepatocellular Carcinoma

Unknown status·SSun Yat-sen University··NCT05889949·200 enrolled

The Study of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma

Completed·PPeking University Cancer Hospital & Institute·Phase 2·NCT04542837·55 enrolled

To Study the Effects of Addition of Mebendazole to Lenvatinib in Cirrhotics With Advanced Hepatocellular Carcinoma.

Unknown status·IInstitute of Liver and Biliary Sciences, India·N/A·NCT04443049·170 enrolled

A Study to Evaluate Safety and Efficacy of Armored CAR-T Cell Injection C-CAR031 in Advanced Hepatocellular Carcinoma

Recruiting·ZZhejiang University·Phase 1·NCT05155189·72 enrolled

Comparison of Response Between Combination of Transarterial Chemoembolization and Lenvatinib Therapy Versus Lenvatinib Monotherapy in Patients With Unresectable Hepatocellular Carcinoma

Recruiting·—·N/A·NCT07408804·40 enrolled

Thyroid Cancer8 trials

A Retrospective and Prospective Real-world Study of Molecular Typing in the Treatment of Advanced Thyroid Cancer

Recruiting·FFudan University·Phase 4·NCT06195228·800 enrolled

Phase II Study Assessing the Efficacy and Safety of Lenvatinib for Anaplastic Thyroid Cancer

Completed·TTranslational Research Center for Medical Innovation, Kobe, Hyogo, Japan·Phase 2·NCT02726503·39 enrolled

Expanded Access Program With Lenvatinib for the Treatment of Differentiated Thyroid Cancer in Brazil

Approved for marketing· Eisai logo

Eisai··NCT03533361

Show 5 more trials

Lenvatinib and Pembrolizumab for the Treatment of Stage IVB Locally Advanced and Unresectable or Stage IVC Metastatic Anaplastic Thyroid Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04171622·25 enrolled

Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)

Recruiting·WWashington University School of Medicine·Phase 2·NCT07092514·34 enrolled

A Trial of Lenvatinib (E7080) in Radioiodine (131 I)-Refractory Differentiated Thyroid Cancer in China

Completed· Eisai logo

Eisai·Phase 3·NCT02966093·151 enrolled

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC)

Completed· Eisai logo

Eisai·Phase 3·NCT01321554·392 enrolled

An Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer

Approved for marketing· Eisai logo

Eisai··NCT02211222

Intrahepatic Cholangiocarcinoma7 trials

Cryoablation Combined With Sintilimab Plus Lenvatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma

Completed·FFudan University·Phase 2·NCT05010668·28 enrolled

Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma

Withdrawn·SSun Yat-sen University·Phase 2·NCT03801499

Two-cohort Study of Toripalimab(PD1)+Lenvatnib, or Gemox+Lenvatinib in Advanced Intrahepatic Cholangiocarcinoma

Completed·SShanghai Zhongshan Hospital·Phase 2·NCT04361331·61 enrolled

Show 4 more trials

Combined HAIC, Lenvatinib and Pucotenlimab As Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma

Recruiting·TTongji Hospital·Phase 2·NCT06192797·36 enrolled

Combined DEB-TACE, Lenvatinib and Pucotenlimab as Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma

Unknown status·TTongji Hospital·Phase 2·NCT06192784·36 enrolled

Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Durvalumab and Lenvatinib in Patients With Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma: a Phase 2 Study(HAIC-quad Trial)

Recruiting·WWest China Hospital·Phase 2·NCT06859684·25 enrolled

Cryoablation Combined With Lenvatinib Plus QL1706 (Iparomlimab/Tuvonralimab) in Patients With Advanced Intrahepatic Cholangiocarcinoma

Recruiting·FFudan University·Phase 2·NCT07070700·56 enrolled

Lenvatinib7 trials

First-Line Lenvatinib in Child-Pugh B Patients With HCC Unsuitable for Curative Treatment

Not yet recruiting·NNational Cancer Center, Korea·Phase 2·NCT07297654·50 enrolled

Lenvatinib Plus TACE Versus Sorafenib Plus TACE for HCC With PVTT

Unknown status·—·Phase 4·NCT04127396·72 enrolled

Lenvatinib Plus VIC-1911 in Lenvatinib-unresponsive or Lenvatinib-resistant HCC

Unknown status·RRenJi Hospital·N/A·NCT05718882·30 enrolled

Show 4 more trials

Ablation in Combination With Lenvatinib and Anti-PD-1 Antibodies

Recruiting·HHua Li·Phase 1·NCT05803928·70 enrolled

Crossover Study to Evaluate the Relative Bioavailability and Palatability of a Lenvatinib Suspension Compared to the Capsule Formulation in Adult Healthy Volunteers

Completed· Eisai logo

Eisai·Phase 1·NCT02792829·60 enrolled

HAIC Plus Lenvatinib vs HAIC Plus Sorafenib for Advanced HCC

Unknown status·SSun Yat-sen University·Phase 3·NCT03775395·250 enrolled

SBRT Plus Lenvatinib and TACE for Advanced Primary HCC: A Phase 3 Trial (SEARCH)

Not yet recruiting·SSun Yat-sen University·Phase 3·NCT05718232·136 enrolled

Renal Cell Carcinoma6 trials

A Study to Evaluate MEDI5752 and Axitinib in Subjects With Advanced Renal Cell Carcinoma

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT04522323·67 enrolled

A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT04736706·1,653 enrolled

Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma

Terminated·CCoImmune·Phase 2·NCT04203901·16 enrolled

Show 3 more trials

A Trial to Evaluate Efficacy and Safety of Lenvatinib in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Non Clear Cell Renal Cell Carcinoma (nccRCC) Who Have Not Received Any Chemotherapy for Advanced Disease

Completed· Eisai logo

Eisai·Phase 2·NCT02915783·41 enrolled

Study of Lenvatinib in Combination With Everolimus in Participants With Unresectable Advanced or Metastatic Renal Cell Carcinoma (RCC)

Completed· Eisai logo

Eisai·Phase 1·NCT02454478·7 enrolled

Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma

Completed· Eisai logo

Eisai·Phase 2·NCT03173560·343 enrolled

69 more indications

Pembrolizumab6 trials

Lenvatinib Combined Pembrolizumab in Advanced Hepatobiliary Tumors

Completed·PPeking Union Medical College Hospital·Phase 2·NCT03895970·32 enrolled

Investigation of Predictive Biomarkers in Patients With Advanced BTC Treated With Lenvatinib Plus Pembrolizumab

Recruiting·—··NCT06648057·100 enrolled

Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT06036836·163 enrolled

Show 3 more trials

A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors

Completed· Eisai logo

Eisai·Phase 1/2·NCT05091346·89 enrolled

Lenvatinib and Pembrolizumab With or Without BCAA in Unresectable HCC

Not yet recruiting·FFudan University·Phase 2·NCT07412054·234 enrolled

A Trial of Lenvatinib (E7080) Plus Pembrolizumab in Participants With Selected Solid Tumors

Completed· Eisai logo

Eisai·Phase 1/2·NCT02501096·357 enrolled

PD-1antibody5 trials

Lenvatinib Plus PD-1 Antibody for Intermediate-stage HCC Beyond Up-to-seven Criteria

Withdrawn·SShi Ming·Phase 2·NCT03775707

Phase II of Lenvatinib Plus PD-1 Antibody for Advanced HCC

Withdrawn·SSun Yat-sen University·Phase 2·NCT03746249

Lenvatinib Plus PD-1 Antibody Versus Lenvtinib Alone for Advanced HCC

Withdrawn·SSun Yat-sen University·Phase 3·NCT03744247

Show 2 more trials

HAIC Plus Lenvatinib and PD-1 Antibody Versus HAIC Plus Lenvatinib for Advanced HCC

Withdrawn·SSun Yat-sen University·Phase 2·NCT03803254

Lenvatinib Plus PD-1 Antibody for Unresectable ICC

Suspended·SShi Ming·Phase 2·NCT03779100·25 enrolled

Ovarian Cancer5 trials

Lenvatinib Plus Toripalimab for Platinum-Resistant Recurrent Ovarian Cancer

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT06241105·69 enrolled

Lenvatinib and Weekly Paclitaxel for Patients With Recurrent Endometrial or Ovarian Cancer

Completed·FFloor Backes·Phase 1·NCT02788708·26 enrolled

Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer

Active, not recruiting·—·Phase 2·NCT05296512·30 enrolled

Show 2 more trials

Envafolimab, Lenvatinib Combined With VP-16 in Platinum-resistant Recurrent Epithelial Ovarian Cancer

Unknown status·ZZhongda Hospital·Phase 2·NCT05422183·20 enrolled

Pembrolizumab and Lenvatinib for the Treatment of Serous Ovarian Cancer Patients

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05114421·30 enrolled

Small Cell Lung Cancer4 trials

Study of Pembrolizumab, Lenvatinib and Chemotherapy Combination in First Line Extensive-stage Small Cell Lung Cancer

Recruiting·FFundación GECP·Phase 2·NCT05384015·46 enrolled

Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) [MK-7902-007/E7080-G000-314/LEAP-007] - China Extension Study

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT04676412·107 enrolled

Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT04938817·110 enrolled

Show 1 more trial

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT03829332·623 enrolled

Melanoma4 trials

Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) for Advanced Melanoma in Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/L1)-Exposed Participants (MK-7902-004/E7080-G000-225/LEAP-004)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT03776136·103 enrolled

Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advanced Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)-China Extension Study

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT04889118·131 enrolled

Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT03820986·674 enrolled

Show 1 more trial

Pembrolizumab/Lenvatinib With and Without Healthy Donor FMT (hdFMT) in Relapsed/ Refractory (R/R) Melanoma

Withdrawn·DDiwakar Davar·Phase 2·NCT06030037

Liver Cancer4 trials

CXD101 in Immunotherapy-related Liver Cancer

Recruiting·SStephen Chan Lam·Phase 2·NCT05873244·44 enrolled

Safety and Efficacy of Paclitaxel Liposome Arterial Infusion Combined With Systemic Therapy for Second-Line Treatment of Advanced Liver Cancer

Not yet recruiting· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 1/2·NCT07282509·116 enrolled

Gut Microbiota in Liver Cancer (Treated With TKIs In Combination With ICIs)

Not yet recruiting·XXu Yong, MD·Phase 2·NCT06563934·70 enrolled

Show 1 more trial

Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer

Recruiting·—·Phase 2·NCT05168163·122 enrolled

First-line Treatment4 trials

Lenvatinib Plus Tislelizumab With or Without TACE in First-line Treatment of Unresectable HCC

Unknown status·PPeking Union Medical College Hospital·Phase 1/2·NCT05842317·60 enrolled

Lenvatinib Plus Tislelizumab and CapeOX as First-Line Treatment for Advanced GC/GEJC With Positive PD-L1 and Low TMEscore

Recruiting·NNanfang Hospital, Southern Medical University·Phase 2·NCT06157996·92 enrolled

A Study to Assess the Safety and Efficacy of Lenvatinib as First-line Treatment in Participants With Unresectable HCC

Completed· Eisai logo

Eisai·Phase 4·NCT04297254·50 enrolled

Show 1 more trial

Adebrelimab Combined with Irinotecan Liposomes, 5-FU, CF ± Lenvatinib As First-line Treatment for Advanced ICC

Not yet recruiting·HHarbin Medical University·Phase 2·NCT06648525·68 enrolled

Gastric Cancer4 trials

Lenvatinib With Taxane Drugs Treatment for Advanced Gastric Cancer

Unknown status·RRuijin Hospital·Phase 1·NCT05171530·19 enrolled

Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients

Recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT06383559·39 enrolled

Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy

Recruiting·QQilu Hospital of Shandong University·Phase 2·NCT05585580·59 enrolled

Show 1 more trial

Cryoablation Combined With Tislelizumab Plus Lenvatinib In Previously Treated Gastric Cancer Liver Metastasis (CASTLE-09)

Unknown status·FFudan University·Phase 2·NCT05893056·25 enrolled

Biliary Tract Cancer4 trials

Cryoablation Combined With Sintilimab Plus Lenvatinib in Patients With Immune Checkpoint Inhibitor Previously Treated Advanced Biliary Tract Cancer （CASTLE-08）

Unknown status·FFudan University·Phase 2·NCT05781074·25 enrolled

Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer

Not yet recruiting·PPeking Union Medical College Hospital·Phase 2·NCT07159217·65 enrolled

Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy

Completed· Eisai logo

Eisai·Phase 2·NCT02579616·29 enrolled

Show 1 more trial

Oncolytic Virotherapy Combined With Tislelizumab Plus Lenvatinib in Patients With Advanced Biliary Tract Cancer (OPTIONS-05)

Unknown status·FFudan University·Phase 2·NCT05823987·25 enrolled

Endometrial Carcinoma3 trials

Lenvatinib in Second Line Endometrial Carcinoma

Withdrawn·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT03005015

Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT04865289·130 enrolled

Phase 1 Clinical Trial of Lenvatinib, Pembrolizumab and Hypofractionated Pelvic Radiation Therapy for pMMR Recurrent/Unresectable Endometrial Carcinoma

Recruiting·AAaron Wolfson·Phase 1·NCT05603910·18 enrolled

Breast Cancer3 trials

Lenvatinib+Letrozole Versus Fulvestrant in Metastatic ER+/HER2- Breast Cancer, Post Progression on Al + CDK4/6 Inhibitor

Recruiting·NNational University Hospital, Singapore·Phase 2·NCT05181033·120 enrolled

Neoadjuvant Lenvatinib Combined With Letrozole in Hormone Receptor Positive Breast Cancer

Active, not recruiting·NNational University Hospital, Singapore·Phase 1/2·NCT02562118·40 enrolled

The Efficacy and Safety of Lenvatinib Combined With Sindilimab and Nab-paclitaxel in the First-line Treatment for Recurrent and Metastatic Triple Negative Breast Cancer: a Phase Ib/IIa Clinical Trial.

Not yet recruiting·ZZhejiang Cancer Hospital·Phase 1/2·NCT06140576·58 enrolled

Advanced Solid Tumors3 trials

Lenvatinib Plus PD-1 Inhibitor for Advanced Solid Tumors With 11q13 Amplification

Not yet recruiting·TTongji Hospital·Phase 2·NCT07417501·60 enrolled

GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors

Recruiting·GGI Innovation, Inc.·Phase 1/2·NCT04977453·317 enrolled

Phase 1 Study to Determine the Effect of Lenvatinib (E7080) on the Pharmacokinetics of Midazolam in Subjects With Advanced Solid Tumors

Completed· Eisai logo

Eisai·Phase 1·NCT02686164·51 enrolled

Safety and Efficacy3 trials

Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced HCC

Recruiting·RRenJi Hospital·N/A·NCT06519721·15 enrolled

Safety and Efficacy of Radiation Plus TACE and Lenvatinib in Advanced HCC With PVTT

Withdrawn·SSun Yat-sen University·N/A·NCT05592197

Safety and Efficacy of Lenvatinib in Subjects With HCC Progression After First Line Treatment With Checkpoint Inhibitors

Terminated·HHumanity & Health Medical Group Limited··NCT04428437·17 enrolled

Locally Advanced3 trials

Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy

Recruiting·AAGO Research GmbH·Phase 2·NCT05903833·42 enrolled

Pembrolizumab and Lenvatinib After Definitive Chemoradiation of Locally Advanced HNSCC

Active, not recruiting·UUniversität des Saarlandes·Phase 2·NCT05433116·50 enrolled

A Study of BL-B01D1+TKI±Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06962787·260 enrolled

Brain Metastases2 trials

Study of Lenvatinib Plus Pembrolizumab in IO Refractory mRCC Patients With Brain Metastases

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT07011849

Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05064280·104 enrolled

Unresectable2 trials

Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC

Recruiting·SSecond Affiliated Hospital of Guangzhou Medical University·Phase 2·NCT05992584·30 enrolled

HAIC+Lenvatinib+Tislelizumab vs D-TACE+Lenvatinib+Tislelizumab for Unresectable HCC

Unknown status·WWen Li·Phase 2·NCT05582278·60 enrolled

PD-1 Inhibitors2 trials

HAIC Combine With Lenvatinib and PD-1 Inhibitors for Advanced HCC With PVTT

Completed·PPeking University·Phase 2·NCT05166239·66 enrolled

HAIC in Combination With PD-1 Inhibitors and Lenvatinib for High Tumor Burden Advanced HCC (CHANCE2416)

Completed·FFirst Hospital of China Medical University··NCT06631326·244 enrolled

Head and Neck Squamous Cell Carcinoma2 trials

Testing Lenvatinib and Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT03524326·24 enrolled

Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT04428151·408 enrolled

Liver Transplant2 trials

IMRT Plus PD-1 Blockade and Lenvatinib for HCC With PVTT (Vp3) Before Liver Transplantation

Unknown status·RRenJi Hospital·N/A·NCT05339581·78 enrolled

Adjuvant Lenvatinib Prevents Recurrence of High-risk Patients With HBV-related HCC After Liver Transplantation

Completed·JJinyang Gu··NCT04415567·23 enrolled

Solid Tumors2 trials

Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors

Recruiting·33D Medicines (Sichuan) Co., Ltd.·Phase 1/2·NCT05024214·170 enrolled

Cryoablation Combined with Tislelizumab Plus Lenvatinib in Previously Treated Solid Tumors (CASTLE-11)

Recruiting·FFudan University·Phase 2·NCT06032845·25 enrolled

Advanced Biliary Tract Carcinoma2 trials

Pembrolizumab in Combination With Lenvatinib in Patients With Advanced Biliary Tract Carcinoma

Completed·—·Phase 2·NCT04550624·27 enrolled

Lenvatinib Combined With PD-1 Inhibitors as First-line Treatment for Unresectable/Advanced Biliary Tract Carcinoma

Unknown status·TThe First Hospital of Jilin University·Phase 2·NCT05509478·46 enrolled

Soft Tissue Sarcoma2 trials

Lenvatinib for Advanced Bone and Soft Tissue Sarcoma

Recruiting·HHenan Cancer Hospital·Phase 2·NCT05617859·60 enrolled

Lenvatinib and Eribulin in Advanced Soft Tissue Sarcoma

Completed·NNational Taiwan University Hospital·Phase 1/2·NCT03526679·30 enrolled

Cholangiocarcinoma2 trials

Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2·NCT05532059·100 enrolled

Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 3·NCT05823311·80 enrolled

Sintilimab2 trials

Lenvatinib+Sintilimab+TACE vs. Lenvatinib+TACE for Advanced HCC

Recruiting·SSecond Affiliated Hospital of Guangzhou Medical University·Phase 3·NCT05608200·427 enrolled

Cryoablation Combined With Sintilimab Plus Lenvatinib in 1L Treatment of Advanced ICC (CASTLE-ICC-Chemo-free)

Unknown status·FFudan University·Phase 2·NCT05835245·30 enrolled

Efficacy and Safety2 trials

A Study to Evaluate Efficacy and Safety of Lenvatinib Combined With Tislelizumab in Patients With FHRCC

Unknown status·RRenJi Hospital·Phase 2·NCT05877820·10 enrolled

To Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Participants With Selected Solid Tumors

Completed· BeiGene logo

BeiGene·Phase 2·NCT05014828·58 enrolled

Metastasis2 trials

Cryoablation Combined with Sintilimab Plus Lenvatinib in Previously Treated Unresectable Liver Metastasis from Solid Tumors

Recruiting·FFudan University·Phase 2·NCT05098847·25 enrolled

Systemic Chemotherapy, Lenvatinib Plus Sintilimab for ICC With Distant Metastasis

Unknown status·SSun Yat-sen University·Phase 2·NCT04769908·40 enrolled

Triple-Negative Breast Cancer2 trials

Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)

Recruiting·UUniversity of Illinois at Chicago·Phase 1·NCT04427293·12 enrolled

HIM Typing Guides the Treatment of Advanced First-Line Triple-Negative Breast Cancer

Not yet recruiting·FFudan University·Phase 2·NCT06849492·120 enrolled

Endometrial Cancer2 trials

Study of Cadonilimab (AK104) Plus Lenvatinib in Patients With Advanced Endometrial Cancer

Active, not recruiting·SSun Yat-sen University·Phase 2·NCT05824481·32 enrolled

Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial Cancer

Terminated·VVirginia Commonwealth University·Phase 2·NCT05263492·4 enrolled

Osteosarcoma2 trials

Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma

Completed· Eisai logo

Eisai·Phase 1/2·NCT02432274·117 enrolled

A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma

Completed· Eisai logo

Eisai·Phase 2·NCT04154189·81 enrolled

Second-line Treatment2 trials

AMG510 (sotorasib) Plus Lenvatinib As Second-line Treatment in Patients with KRASG12C Mutant, Metastatic NSCLC

Withdrawn·EETOP IBCSG Partners Foundation·Phase 2·NCT06068153

Efficacy and Safety of Nab-paclitaxel-Lenvatinib-Pembrolizumab as Second-line Treatment in Advanced NSCLC Patients

Not yet recruiting·PPeking University First Hospital·Phase 2·NCT06028633·28 enrolled

Advanced2 trials

HAIC Plus Lenva and PD-1 for Advanced HCC With Macrovascular or Biliary Invasion

Not yet recruiting·PPeking University··NCT07466225·150 enrolled

bTAE-HAIC Combined With System Therapy for Intermediate-advanced Huge HCC

Recruiting·SSun Yat-sen University·N/A·NCT06061276·40 enrolled

Patients With Advanced Solid Tumors1 trial

Erlotinib in Combination With Select Tyrosine Kinase Inhibitors in Adult Patients With Advanced Solid Tumors

Withdrawn·NNational Cancer Institute (NCI)·Phase 1·NCT06161558

Neuroendocrine Tumors1 trial

Phase II Study of Pembrolizumab and Lenvatinib in Advanced Well-differentiated Neuroendocrine Tumors

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT03290079·20 enrolled

Advanced Solid Tumours1 trial

A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours

Recruiting·LLaNova Medicines Limited·Phase 1/2·NCT06682780·320 enrolled

Metastatic Renal Cell Cancer1 trial

Lenvatinib With Everolimus Versus Cabozantinib for Second-Line or Third-Line Treatment of Metastatic Renal Cell Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05012371·90 enrolled

Mucosal Melanoma1 trial

Lenvatinib and Pembrolizumab in Resectable Mucosal Melanoma

Unknown status·PPeking University Cancer Hospital & Institute·Phase 2·NCT04622566·26 enrolled

Metastatic Cancer1 trial

Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer

Active, not recruiting·SSalubris Biotherapeutics Inc·Phase 1/2·NCT05620134·263 enrolled

Portal vein thrombosis1 trial

Phase Ib/II Trial of Combining Pembrolizumab and Lenvatinib With SBRT for HCC Patients With Portal Vein Thrombosis.

Not yet recruiting·NNational Taiwan University Hospital·Phase 1/2·NCT05286320·27 enrolled

Postoperative Adjuvant Therapy1 trial

Exploration of Postoperative Adjuvant Therapy for HCC Patients With Positive TB

Not yet recruiting·SSecond Affiliated Hospital of Xi'an Jiaotong University·Phase 4·NCT07160361·56 enrolled

Neoadjuvant1 trial

Neoadjuvant and Adjuvant Lenvatinib in HCC Patients Treated by Percutaneous Ablative

Active, not recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT05113186·32 enrolled

Differentiated Thyroid Carcinoma1 trial

Study of the Efficacy of Lenvatinib Combined With Denosumab in the Treatment of Patients With Predominant Bone Metastatic Radioiodine Refractory Differentiated Thyroid Carcinomas

Unknown status·CCentre Leon Berard·Phase 2·NCT03732495·35 enrolled

Pancreatic Cancer1 trial

Lenvatinib and Pembrolizumab Maintenance Therapy for the Treatment of Patients of Advanced Unresectable Pancreatic Cancer

Recruiting·—·Phase 2·NCT04887805·28 enrolled

Adjuvant Treatment1 trial

Pembrolizumab Plus Lenvatinib in REcurrent ccRCC Patients Failing permbroLizUmab aDjuvant trEatment

Not yet recruiting·GGruppo Oncologico Italiano di Ricerca Clinica·Phase 2·NCT07460206·108 enrolled

Chemotherapy1 trial

Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study

Recruiting·SShanghai Junshi Bioscience Co., Ltd.·Phase 3·NCT05342194·480 enrolled

Systemic Therapy1 trial

HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC

Recruiting·FFirst Hospital of China Medical University··NCT06632093·84 enrolled

Adenoid Cystic Carcinoma1 trial

Testing Lenvatinib in Patients With Adenoid Cystic Carcinoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT02780310·33 enrolled

Carcinoid Tumor1 trial

Lenvatinib and Everolimus in Treating Patients With Advanced, Unresectable Carcinoid Tumors

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03950609·36 enrolled

Adenocarcinoma1 trial

Study of the Safety and Activity of Lenvatinib (E7080) in Subjects With KIF5B-RET-Positive Adenocarcinoma of the Lung

Completed· Eisai logo

Eisai·Phase 2·NCT01877083·25 enrolled

Malignant Pleural Mesothelioma1 trial

Pembrolizumab Plus Lenvatinib In Second Line and Third Line Malignant Pleural mesotheLioma Patients

Active, not recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT04287829·58 enrolled

Rectal Adenocarcinoma1 trial

Capecitabine and Lenvatinib With External Radiation in Rectal Adenocarcinoma

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT02935309·20 enrolled

Envafolimab1 trial

Study on Therapeutic Effect of Combination of Envafolimab, Lenavatinib and TACE in Advanced HCC Patients

Completed·ZZhejiang University·Phase 2·NCT05213221·39 enrolled

Cancer1 trial

OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults

Unknown status·UUniversity Medical Center Groningen·Phase 4·NCT05949424·30 enrolled

Esophageal Adenocarcinoma1 trial

Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT05041153·15 enrolled

Lymphoma1 trial

A Study to Determine the Metabolism and Elimination of 14C-E7080 in Patients With Advanced Solid Tumors or Lymphomas, Who Are Unsuitable For, or Have Failed, Existing Therapies.

Completed· Eisai logo

Eisai·Phase 1·NCT02578316·6 enrolled

Trial1 trial

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

IDH1 Mutation1 trial

An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy.

Recruiting·PPeking Union Medical College Hospital·Phase 2·NCT07282262·300 enrolled

Thymic Carcinoma1 trial

First-line CBDCA/PTX/LEN/Pembrolizumab Combination for Previously Untreated Advanced or Recurrent Thymic Carcinomas (Artemis)

Recruiting·NNational Cancer Center, Japan·Phase 2·NCT05832827·35 enrolled

Metastatic Colorectal Cancer1 trial

Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT04776148·563 enrolled

Neoadjuvant Therapy1 trial

Neoadjuvant Therapy in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model

Recruiting·CChen Xiaoping·Phase 2·NCT06420440·160 enrolled

Toripalimab1 trial

Phase II of Lenvatinib Plus Toripalimab for Advanced HCC

Withdrawn·SSun Yat-sen University·Phase 2·NCT03919383

Uveal Melanoma1 trial

Lenvatinib Plus Pembrolizumab In Patients With Immune Checkpoint Inhibitor Naïve Metastatic Uveal Melanoma

Active, not recruiting·PProvidence Health & Services·Phase 2·NCT05308901·6 enrolled

Biliary Tract Tumors1 trial

Tisleizumab Combined With Lenvatinib and XELOX Regimen (Oxaliplatin Combined With Capecitabine) in the First-line Treatment of Advanced and Unresectable Biliary Tract Tumors

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT05291052·20 enrolled

Advanced Stage1 trial

Immune Checkpoint Therapy vs Target Therapy in Reducing Serum HBsAg Levels in Patients With HBsAg+ Advanced Stage HCC

Recruiting·HHumanity & Health Medical Group Limited·Phase 2·NCT03899428·30 enrolled

Biliary Tract Carcinoma1 trial

Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma

Not yet recruiting·YYunpeng Liu·N/A·NCT06463548·30 enrolled

PD-1 Inhibitor1 trial

TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced HCC With Main Trunk PVTT

Recruiting·SSun Yat-sen University·N/A·NCT06622031·42 enrolled

Clinical Trial1 trial

CARE1 Pragmatic Clinical Trial

Recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Phase 3·NCT06364631·1,250 enrolled

Glioblastoma1 trial

Lenvatinib, Pembrolizumab, and Tumor Treating Fields (TTFields) for Second-line Treatment of Glioblastoma

Withdrawn·—·Phase 1/2·NCT05973903

Tislelizumab1 trial

A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence

Not yet recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 3·NCT07475026·198 enrolled

Unspecified1 trial

An Open Label Dose Escalation Study Of E7080

Completed· Eisai logo

Eisai·Phase 1·NCT00121719·82 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 13, 2015

LENVIMA

NDA NDA206947

Sources

References

[1]
ClinicalTrials.gov — 420 trial records for Lenvatinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Lenvima drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Lenvatinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Lenvatinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA206947). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Lenvima. U.S. Food & Drug Administration.
[7]
PubMed — 2 publications indexed for Lenvatinib. U.S. National Library of Medicine.
[8]
SEC EDGAR — Eisai company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Multi-Kinase VEGFR Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Eisai

Patent Landscape[6]

Patent Cliff

Sep 19, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7253286Oct 24, 2025

7253286*PEDApr 24, 2026

7612208Sep 19, 2026

7612208*PEDMar 19, 2027

9006256Jul 27, 2027

15 more patents

9006256*PEDJan 27, 2028

12508313Oct 4, 2030

12508313*PEDApr 4, 2031

10407393Aug 26, 2035

10259791Aug 26, 2035

11186547Aug 26, 2035

11090386Feb 23, 2036

10259791*PEDFeb 26, 2036

10407393*PEDFeb 26, 2036

11186547*PEDFeb 26, 2036

12083112Mar 3, 2036

11090386*PEDAug 23, 2036

12083112*PEDSep 3, 2036

12226409May 15, 2038

12226409*PEDNov 15, 2038

Key Publications[7]

Lenvatinib Plus Pembrolizumab First-Line in HCC: LEAP-002

Lancet OncolApr 10, 2023DOI: 10.1016/S1470-2045(23)00083-4

Lenvatinib Plus Pembrolizumab in Advanced Endometrial Cancer: KEYNOTE-775

N Engl J MedFeb 3, 2022DOI: 10.1056/NEJMoa2201517